nifedipine

Product NDC
21695-807
11-digit product format
216950807
Labeler code
21695
Product ID
21695-807_b10b3eaf-c28d-4d09-93e0-64c3d4090c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077410
Marketing category
ANDA
Marketing start
2007-10-03
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
90 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-807-30nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
21695-807-90nifedipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-807NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110428_b10b3eaf-c28d-4d09-93e0-64c3d4090c78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNb10b3eaf-c28d-4d09-93e0-64c3d4090c781
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDb10b3eaf-c28d-4d09-93e0-64c3d4090c781
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYb10b3eaf-c28d-4d09-93e0-64c3d4090c781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-807-302169508073030 in 1 BOTTLEHistorical
21695-807-902169508079090 in 1 BOTTLEHistorical